1、安全审查简介Introduction of Safety Review拜耳医药保健有限公司北京工厂BHC Product Supply Beijing Site2012年3月March, 2012,Introduction of Safety Review Page 2 March, 2012,内容Content,拜耳集团工艺与工厂安全规范 Bayer Group Process and Plant Safety Regulations安全概念的建立 Development of Safety Concepts 安全审查的程序 Procedures of Safety Review降低风险的基
2、本原理 Basic Principles to Reduce Risk,拜耳集团工艺与工厂安全规范Bayer Group Process and Plant Safety Regulations,政策方针PolicyBayer集团工艺及工厂安全Process & Plant Safety in the Bayer Group集团规定No. 2020 Group Regulation No. 2020 生效日期: 2010年4月1日Effective: April 1, 2010,指令Directive工艺及工厂安全Process and Plant Safety集团规定No. 13-1 Gro
3、up Regulation No. 13-1 生效日期: 2004年10月1日Effective: October 01, 2004,导则Guideline工艺及工厂安全纲要Process and Plant Safety Compendium集团规定No. 1928 Group Regulation No. 1928 生效日期：2007年7月1日Effective: July 01, 2007,操作规程Procedure厂房、设备及公用系统的安全状态回顾Safety Status Review for Facilities, Equipment and Systems标准操作规程 S 25-
4、046SOP S 25-046生效日期：2010年3月29日Effective: March 29, 2010,工艺及工厂安全指令和标准操作规程Directive and SOP of Process and Plant Safety,DirectiveProcess & Plant Safety,安全概念 Safety concept工作流程 (含各级证书)Work flow (with certificates) 初步安全分析 (A1) Preliminary Safety Analysis (A1) 基础安全审查 (A2) Basic Safety Review (A2)详细安全审查 (
5、A3) Detailed Safety Review (A3) 开车前安全审查 (A4) Pre Start-Up Safety Review (A4)角色和职责 Roles and responsibilities,对于每个工艺和工厂，安全概念必须建立、存在。For every process and plant a safety concept must be developed and in place,For Reference,A4-R,A3-R,生产 / 运行阶段Production / Operation-Phase,R =重新评估R = Revalidation,A1, A2,
6、 A3,A4,安全概念的建立Development of Safety Concepts,计划Plan,实施Do,行动Act,检查Check,安全审查的程序Procedures of Safety Review,A1初步安全分析A1 Preliminary Safety Analysis,A2 基本安全审查A2 Basic Safety Review,A3 详细安全审查A3 Detailed Safety Review,A4 运行前的安全审查A4 Pre Start-Up Safety Review,重新评估Revalidation,随着项目的进展，对安全设计概念进行逐步的，细化的安全评估。S
7、tepwise review of safety concepts with increasing detailed investigation during the developing of project phases.,工作步骤：A1 初步安全分析Work Stage: A1 Preliminary Safety Analysis,工作步骤： A2 基础安全审查Work Stage: A2 Basic Safety Review,工作步骤： A3 详细安全审查Work Stage: A3 Detailed Safety Review,A3审查阶段Review Stage A3,系统地辨
8、识危害 systematic identification of the hazards 风险评估risk assessment 确定适当的安全措施 definition of adequate preventive and mitigating safety measures,详细安全审查证书Detailed Safety Review Certificate:在采购之前获得Prior to the procurement of plant components,工作步骤：A4 运行前安全审查Work Stage: A4 Pre Start-Up Safety Review,A4 审查阶段R
9、eview Stage A 4,运行前安全审查证书Pre Start-Up Safety Review Certificate:在运行前获得Prior to start up of the plant,检查在A3中提到的要求是否实现以及工厂是否按照之前讨论的结果来建设checked whether all required defined measures which were specified in the detailed safety review (A3) have been realized and the plant is build as discussed 检查，检查及功能性
10、测试 plant inspections, checks and functional equipment testing,工作步骤：定期再评审Work Stage: Periodic Review,开车Start Up,生产 / 操作 Production / Operation,A4,变更Modifications,R =重新评估的R = Revalidation,MoC= 变更管理MoC= Management of change,安全审查参与成员Participants of Safety Reviews,技术检查Technical Inspection,同一人员也可能会同时担任多个角
11、色Several functions may be assumed by a same person,安全审查文件的重要性Safety Review Documentation,安全审查的相关文件是工艺和工厂方面信息的最重要来源。它确保下列工作安全并且正确地执行：The safety review documentation is one of the most important sources of information for a specific process or plant. It makes it possible to safely and correctly perfor
12、m tasks such as: 预防性维护 Preventive maintenance故障应急维护 Emergency maintenance and breakdowns过程变更 Process changes 员工培训 Employee training按照法律要求准备和更新安全报告 Preparation and updating of safety reports in compliance with legal requirements.,降低风险的基本原理Basic Principles to Reduce Risk,风险= 结果的严重程度 x 事件发生的可能性Risk = C
13、onsequence Severity x Event Frequency,1. 消除危害或者将潜在的危害最小化 Eliminate or minimize potential hazard2. 避免失误或者将潜在的失误降到最低 Avoid or Minimize potential failures3. 把工艺或过程设计成失误-可接受 Design processes and plants to be fault-tolerant 4.减轻可能的事件的影响 Mitigate the effects of potential incidents,降低风险-工作流程Reduce Risk-Wor
14、k Flow,危险识别Hazard identification,用风险矩阵鉴定风险级别Identification of risk class with risk matrix,频率 Frequency,严重性Severity,安全措施工具箱Measure tool box,风险评估Risk assessment后果的严重性Severity of consequences情景发生的频率Frequency of scenario,风险降低Risk reduction详细的安全措施Specification of safety measures,可能的风险Scenarios,风险分析文件的结构H
15、azard Analysis Document Structure,工艺描述 DESCRIBE THE PROCESS物质的描述和特性 DESCRIBE AND CHARACTERIZE THE SUBSTANCES通过下面方法进行风险评估 EVALUATE THE RISK VIAHAZOP / FMEA = 评估可能性 HAZOP / FMEA = ESTIMATE THE PROBABILITY (P)结果分析= 评估严重程度 CONSEQUENCE ANALYSIS = ESTIMATE HOW BIG THE PROBLEM IS (E)RISK R = P x E控制风险的措施 C
16、OUNTERMEASURES TO CONTROL THE RISK确定剩余的风险 DEFINE THE RESIDUAL RISK风险分析评估地点的分类CLASSIFY THE PLACE WHERE THE RISK IS EVALUATED爆炸环境(燃烧/爆炸） ATEX (FLAME/EXPLOSION)噪声 NOISE生物的/致突变的/致癌的 BIOLOGICAL/MUTAGENIC/CANCEROGENIC机械的 MECHANICAL建立系统来控制危险 SET UP A SYSTEM TO CONTROL THE DANGER检查 WALKTHROUGH提高意识/培训 AWARENESS / TRAININGS,谢谢！ Thank you!,
